QA Specialist in Cambridge, MA

First shift (Monday – Friday) prefers 7:00am – 3:00pm but flexible to 7:30-3:30pm.

No travel- required to be onsite 5 days a week.

We are seeking a highly skilled and experienced Senior QA Specialist to join our dynamic team. In this role, you will be responsible for overseeing the quality assurance process, ensuring that our products meet both Local and Global quality standards.

Top 3 must-have HARD/TECHNICAL skills

• Batch Record Review experience.
• GMP experience.
• Gown into a manufacturing suite (hair nets, beard covering, gowns), not full face covering.

Responsibilities:

• Execute all activities following quality and regulatory standards and procedures.
• Promote a quality mindset and quality excellence approach to all activities.
• Provide on the floor support to Manufacturing activities.
• Perform review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
• Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, Deviations, and Self inspection auditing, QA reporting and approval of GMP documentation.
• Review and approve Standard Operating Procedures, logbooks and QC data.
• Support batch release of drug substance including compilation of documentation, as necessary.
• Support SAP integration and master data migration, as applicable.
• Support GMP compliance and inspection readiness within organization. Assist in coordination of work for the QA Operations team to facilitate timely release of product lots.

Education Requirements:

We are looking for professionals with these required skills to achieve our goals.

• HS Diploma or equivalent and 8+ years of experience in a cGMP environment.
• OR associate degree and 6+ years of experience in a cGMP environment.
• OR bachelor’s degree and 4+ years of experience in a cGMP environment.
• Previous experience working with quality systems having oversight of cGMP production operations including some or all of the following: batch release, SAP, batch record review.

Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. We specialize in attracting and retaining talent globally for rewarding careers in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, whether in the USA, UK, India, or Ireland. Additionally, we offer Flexible Work Arrangement jobs and contract positions across different verticals and industries.
Rangam strives to put job seekers first, providing them with free access to search for jobs, post resumes, and research companies. Every day, we connect millions of people to new opportunities.